efficacy of cardioviva™ probiotic supplement capsule formulation

Conditions: Hypercholesterolemia

Summary: background: it is becoming increasingly clear that individuals from all corners of the globe use probiotic dietary approaches to enhance health. more recently, probiotics have shown promise in treating a variety of disease states, due to improved strain selection, stability and delivery technologies. objective: the purpose of this study is to determine the lipid lowering efficacy of a probiotic supplement capsule containing lactobacillus reuteri cardioviva™, taken twice per day over 9 weeks, in subjects with hypercholesterolemia. design: the study design is a double-blinded, placebo-controlled, randomized, parallel-arm, multi-centre study. the study will last a total of 13 weeks, including a 2-week wash-out period, a 2-week run-in period and a 9 week treatment period.


Eligibility criteria:
inclusion criteria: * males and females, aged 20 to 75 years (bounds included) * ldl-cholesterol above 3.4 mmol/l (\<15% variation between visits v1 and v2-1) * tg levels below 4.0 mmol/l (checked at visits v0 and v2-1) * bmi range will be 22 to 32 kg/m² * subject understands and accepts to follow the dietary recommendations advisable for hypercholesterolemic patients (according to ncep-atp iii guidelines) * for subjects on statin monotherapy: dosage of statin must be stable for at least 3 months prior to the study beginning (15-20% of all subjects) * judged by the investigators as compliant (\>80%) with product consumption (check at v2-1), and motivated * signed informed consent form prior to inclusion in the study * note: subjects will be permitted to take stable doses of thyroid hormone and anti-hypertensive agents, as long as these are continued equivalently throughout the duration of study * for female subjects: effective contraceptive methods used exclusion criteria: * use of cholesterol lowering prescription drugs other than statin monotherapy within the last 6 months * use of plant sterols, omega 3, fish oil, soy protein, soluble oat fiber, psyllium seed husk, or other cholesterol lowering non-prescription food supplements within last 3 months * history of chronic use of alcohol (\>2 drinks/d) * use of systemic antibodies, corticosteroids, androgens, or phenytoin * subject having experienced any cardiovascular event (myocardial infarction, coronary artery bypass, or other major surgical procedures) in the last 6 months * diabetic subject (type i or type ii) * subject receiving systemic treatment or topical treatment likely to interfere with evaluation of the study parameters * subject currently involved in a clinical trial or in an exclusion period following participation in another clinical trial * history of angina, congestive heart failure, inflammatory bowel disease, pancreatitis, gastrointestinal, renal, pulmonary, hepatic or biliary disease, or cancer (evidence of active lesions, chemotherapy or surgery in the past year) * chronic user of probiotics or fibre laxative (greater than 2 doses/wk), or stimulant laxatives * history of eating disorders * exercise greater than 15 miles/wk or 4,000 kcal/wk * for female subjects: pregnancy, breast feeding, or intent to get pregnant